MalnutritionASUST-MSCNCT06516367
Screening Tool for Malnutrition, Sarcopenia, and Cachexia
An observational study of Malnutrition and Sarcopenia, run by Ain Shams University at 1 site in Egypt.
Trial summary
There is an accumulating evidence of the overlap and frequent co-occurrence of twasting conditions in older adults. Those conditions include malnutrition, sarcopenia, and cachexia, Therefore , a tool capable of simultaneously screening for all three conditions is imperative. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Malnutrition, Sarcopenia, Cachexia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Older adult
Study population: 300 older participants aged 60 years old and above who were admitted to Ain Shams University Hospitals or interviewed at the hospital clinic
Who may be able to join
- Participants Aged 65 years and older, who agree to participate
Who cannot join
- Patients with critical illness.
- Patients with severe cognitive, hearing or visual impairment hindering proper communication
- Patients with physical disability that interfere with physical performance assessment or hand grip measurement
- Patient with any contraindication of to the use of BIA) e.g. presence of a pacemaker, other implanted electrical devices, or metal implants, volume overload
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of a New Tool for Simultaneous Screening of Malnutrition, Sarcopenia, and Cachexia in Older Adults
There is an accumulating evidence of the overlap and frequent co-occurrence of twasting conditions in older adults. Those conditions include malnutrition, sarcopenia, and cachexia, Therefore , a tool capable of simultaneously screening for all three conditions is imperative. In this study, we developed and validated a new tool for the simultaneous screening of muscle wasting diseases in older adults. The diagnostic accuracy of the new tool was compared to other validated screening tools including the Mini Nutritional Assessment-Short Form (MNA-SF), the Short Nutritional Assessment Questionnaire (SNAQ), and the Simple Questionnaire to Rapidly Diagnose Sarcopenia (SARC-F).
- Conditions
- Malnutrition, Sarcopenia, Cachexia
- Being tested
- Ain Shams University Screening Tool for Malnutrition, Sarcopenia, and Cachexia (ASUST-MSC)
- Keywords
- screening, older adult, malnutrition, cachexia, sarcopenia
- Medical subject headings
- Malnutrition, Sarcopenia, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ain Shams University Screening Tool for Malnutrition, Sarcopenia, and Cachexia (ASUST-MSC)Other
Also called bioelectrical impedence analysis, handheld dynamometer
25 items dichotomous questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
reliability of a new tool for the simultaneous screening of muscle wasting diseases in older adults
Relaibility; Cronbach's alpha coefficient was used to evaluate the internal consistency.
Measured: 10 months
validity of a new tool for the simultaneous screening of muscle wasting diseases in older adults
Validity; Spearman's correlation coefficient was used to examine construct validity of the new tool
Measured: 10 months
Secondary outcomes (1)
The diagnostic accuracy of the new tool
The Receiver operating curve was plotted to detect the area under curve of the new tool, for diagnosing muscle wasting diseases.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Jun 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doha Rasheedy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516367
- Sponsor's protocol ID
- Ain Shams Screening tools
- Acronym
- ASUST-MSC
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a New Tool for Simultaneous Screening of Malnutrition, Sarcopenia, and Cachexia in Older Adults
- ClinicalTrials.gov ID
- NCT06516367
- Acronym / sponsor ID
- ASUST-MSC / Ain Shams Screening tools
- Conditions
- Malnutrition, Sarcopenia, Cachexia
- Keywords
- screening, older adult, malnutrition, cachexia, sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is an accumulating evidence of the overlap and frequent co-occurrence of twasting conditions in older adults. Those conditions include malnutrition, sarcopenia, and cachexia, Therefore , a tool capable of simultaneously screening for all three conditions is imperative. In this study, we developed and validated a new tool for the simultaneous screening of muscle wasting diseases in older adults. The diagnostic accuracy of the new tool was compared to other validated screening tools including the Mini Nutritional Assessment-Short Form (MNA-SF), the Short Nutritional Assessment Questionnaire (SNAQ), and the Simple Questionnaire to Rapidly Diagnose Sarcopenia (SARC-F).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- 300 older participants aged 60 years old and above who were admitted to Ain Shams University Hospitals or interviewed at the hospital clinic
Key inclusion criteria (1 listed)
- Participants Aged 65 years and older, who agree to participate
Key exclusion criteria (4 listed)
- Patients with critical illness.
- Patients with severe cognitive, hearing or visual impairment hindering proper communication
- Patients with physical disability that interfere with physical performance assessment or hand grip measurement
- Patient with any contraindication of to the use of BIA) e.g. presence of a pacemaker, other implanted electrical devices, or metal implants, volume overload
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ain Shams University Screening Tool for Malnutrition, Sarcopenia, and Cachexia (ASUST-MSC)Also: bioelectrical impedence analysis, handheld dynamometer25 items dichotomous questionnaire | Other | – |
Primary outcome
reliability of a new tool for the simultaneous screening of muscle wasting diseases in older adults
Time frame: 10 months
Relaibility; Cronbach's alpha coefficient was used to evaluate the internal consistency.
validity of a new tool for the simultaneous screening of muscle wasting diseases in older adults
Time frame: 10 months
Validity; Spearman's correlation coefficient was used to examine construct validity of the new tool
1 secondary outcome
The diagnostic accuracy of the new tool
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition and Sarcopenia, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reliability of a new tool for the simultaneous screening of muscle wasting diseases in older adults (time frame: 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.